EP3434226A1 - Systeme zur platzierung von hornhaut-implantaten - Google Patents

Systeme zur platzierung von hornhaut-implantaten Download PDF

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EP3434226A1
EP3434226A1 EP18181352.8A EP18181352A EP3434226A1 EP 3434226 A1 EP3434226 A1 EP 3434226A1 EP 18181352 A EP18181352 A EP 18181352A EP 3434226 A1 EP3434226 A1 EP 3434226A1
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Prior art keywords
implant
corneal
cornea
pocket
corneal implant
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English (en)
French (fr)
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EP3434226B1 (de
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Yichieh Shiuey
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/142—Cornea, e.g. artificial corneae, keratoprostheses or corneal implants for repair of defective corneal tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/145—Corneal inlays, onlays, or lenses for refractive correction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses, corneal implants; Implanting instruments specially adapted therefor; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2002/16965—Lens includes ultraviolet absorber
    • A61F2002/1699—Additional features not otherwise provided for

Definitions

  • corneal implants There are many different types of corneal implants that have been developed for the treatment of refractive error and disease. Because of limitations in the methods of creating corneal pockets, these implants have all been designed for placement in the cornea by creation of a corneal incision which is either similar in size to the smallest dimension of the implant or larger. Recently, two methods of corneal pocket creation have been devised which can create a pocket with an external opening width that is less than the maximum internal width of the pocket. These two methods are pocket creation by the femtosecond laser and, of particular interest, cornea cutting, as described in US 2004/0243159 and 0243160 , invented by the inventor herein, the full disclosure of which is incorporated herein by reference.
  • a biocompatible corneal implant that can be placed through an external incision that is less than the width of the implant, especially an external incision that is less than half of the width of the implant. It is particularly advantageous if the corneal implant can be placed through an incision that does not require suturing for closure, typically being 3 mm or less. Such a small external incision also decreases induced surgical astigmatism and speeds up the recovery time for the patient. Moreover, it is useful to have a relatively large implant that can be placed through a relatively small incision. For example a lens implant that is larger is more likely to give good quality vision especially in a patient with large pupils. It is also advantageous to have a simple and reliable delivery system for the corneal implant.
  • Intraocular lenses (IOL's) for cataract surgery have been designed to be placed through a small incision. These small incision cataract surgery lenses cannot practically be used within a corneal pocket. Most small incision cataract surgery lens implants are usually too thick to be placed within a corneal pocket. For example the typical thickness of a cataract surgery lens implant is 1 mm or more which is substantially thicker than the human cornea, which is usually between 0.5 to 0.6 mm. Some corneal implants that have been designed only have a thickness of about 0.05 mm. Moreover, the cataract surgery lens implants have haptics, which are extensions from the lens implant designed to keep the lens implant fixated within the capsular bag. Haptics are not present and not necessary for corneal implants. Finally, the cataract surgery lens implants are not designed to be biocompatible with the cornea and would not be tolerated as corneal implants.
  • the delivery systems designed for small incision cataract surgery lens implants are not well adapted for use as a delivery system for small incision corneal implants. These delivery systems have been designed for cataract surgery lens implants that are much thicker than the usual corneal implant.
  • the delivery systems for small incision cataract surgery lens implants are designed to accommodate haptics, which would not be present on a corneal lens implant. It has been found that at least some commercially available corneal implants are destroyed when placed through a standard IOL injector. Similarly, biological corneal implants placed through a standard IOL injector will often show severe histological damage, such as endothelial damage.
  • Corneal implants can be made of either synthetic materials (e.g. prostheses) or can be biological in origin (e.g. transplant grafts).
  • Recently two new surgical techniques for placement of a lamellar corneal stromal endothelial transplant grafts have been devised. These surgical techniques are useful in the treatment of endothelial diseases of the cornea such as Fuchs' endothelial dystrophy and pseudophakic bullous keratopathy.
  • One of these techniques is referred to as deep lamellar endothelial keratoplasty (DLEK).
  • DLEK deep lamellar endothelial keratoplasty
  • a pocket is made within the cornea and diseased corneal endothelium is excised along with a layer of corneal stroma.
  • a lamellar corneal stromal endothelial transplant graft is automatically created using either a microkeratome or a laser. The diseased corneal endothelium is stripped away with surgical instruments and then the lamellar corneal stromal endothelial transplant graft is inserted into the anterior chamber through a full thickness corneal incision. The graft is then held in place against the stripped posterior corneal stromal surface by an air bubble until the graft is able to heal in position.
  • both DLEK and DSAEK it is advantageous to be able to insert a relatively large transplant atraumatically through a small corneal or scleral incision.
  • a larger transplant has more corneal endothelial cells and should produce better results in the treatment of corneal endothelial diseases.
  • a significant problem with prior art methods of inserting corneal transplants into the anterior chamber through a small incision is that they all involve folding of the transplant and grasping of the transplant with forceps.
  • the transplant is typically severely compressed as it passes through the corneal incision. It has been demonstrated through the use of vital staining techniques that many of the delicate corneal endothelial cells of a transplant are killed during the prior art insertion process.
  • corneal inlay prostheses are also very delicate. In many cases, these corneal inlays may be as thin as 30 to 40 microns, which make them very easily torn by forceps. Therefore, there is also a need for an improved method to place these corneal inlays atraumatically through a small incision.
  • IOLs intraocular lenses
  • these delivery systems designed for small incision cataract surgery IOLs are not well adapted for use as a delivery system for corneal implants through a small incision.
  • a typical intraocular lens implant may be 1 mm or more in thickness
  • the typical corneal transplant for DLEK or DSAEK is between 0.1 to 0.15 mm in thickness.
  • the thickness of a corneal inlay prosthesis may be as little as 30 to 40 microns.
  • the size and shape of an IOL is different from that of a corneal transplant.
  • An IOL is typically 12 to 13 mm in length, 5 to 6 mm wide, and 1 mm or more in thickness
  • a corneal transplant DSEK graft would typically be circular in shape and would have a diameter of 8 to 9 mm and a thickness from 0.1 mm to 0.2 mm.
  • the diameter may range from 1 mm to 10 mm and the thickness from 0.01 mm to 0.6 mm.
  • IOL delivery systems are designed to greatly compress the IOL during the insertion process, whereas this type of compression would be likely to either damage or destroy a living corneal transplant. The amount of compression used for IOL delivery systems could also damage the much thinner corneal implants.
  • corneal implant refers to any natural (biological) or synthetic implant or graft that may be implanted into a human cornea.
  • These systems and methods can place a corneal implant through a corneal incision that is substantially less than the width of the implant.
  • the placement of the implant may be within or between any of the layers of the cornea including epithelium, Bowman's membrane, stroma, Descemet's membrane, and endothelium.
  • the corneal incision is equal or less than half of the width of the implant.
  • the system allows the placement of a corneal implant through an incision that is less than or equal to 3 mm, which advantageously avoids the need for suturing of the incision in most cases and also greatly decreases the chance of unwanted induced astigmatism.
  • the corneal implant is reversibly deformable in shape to allow its passage through a corneal incision that is equal or less than half of the width of the implant.
  • the corneal implant is bio-compatible with the cornea, the eye, and the body.
  • synthetic material which can meet these criteria may potentially be used for the implant.
  • Suitable synthetic materials include one or more compounds selected from the group consisting of collagen, polyurethanes, poly(2-hydroxyethylmethacrylate), polyvinylpyrolidone, polyglycerolmethacrylate, polyvinyl alcohol, polyethylene glycol, polymethacrylic acid, silicones, acrylics, polyfluorocarbons, and polymers with phosphocholine.
  • the grafts may comprise human corneas harvested for use in transplants such as grafts or DSEK or a graft which consists only of Descemet's membrane and endothelium. Transplantation of only Descemet's membrane and endothelium is referred to as Descemet's Membrane Endothelial Keratoplasty (DMEK).
  • DMEK Descemet's Membrane Endothelial Keratoplasty
  • biological cornea implants may be obtained from other sources such as animals, genetically modified animals, in vitro cell culture, or the like.
  • the material comprises a hydrogel.
  • the material comprises polymethacrylic acid-co hydroxyethyl methacrylate (PHEMA/MAA).
  • the corneal implant is formed from a material comprising of a reversibly deformable acrylic copolymer, such as those used for intraocular lenses. These materials have excellent tensile strength and can be elongated as much as 250% before breaking. Such characteristics allow injection to be performed according to the present invention without damage to the implant. Examples of suitable materials include copolymers of hydroxyethyl methacrylate and methyl methacrylate (e.g. materials available under the tradenames Contamac C126, C118, C121 materials, Benz IOL 25UV and Benzflex 26UV).
  • the deformable polymer is hydrophilic in nature to allow smooth wetting of the optical surface of the implant.
  • corneal implant which allows the tearfilm to act as a good optical interface.
  • the material contains between 1% and 20% methacrylic acid. More preferably 5 to 10% methacrylic acid, which advantageously allows the linkage of tethering molecules such as polyethylene glycol to the surface of the implant. Tethering molecules will allow reactive moieties to be linked to the surface of the implant to create useful implant characteristics such as promotion of epithelialization or the ability to create chemical bonds with the cornea.
  • Other preferred physical characteristics of the corneal implant material would be a tensile strength in the range of 0.1 to 4 MPa, more preferably a tensile strength in the range of 0.6 to 2.6 MPa.
  • a modulus of 0.1 to 5 MPa more preferably a modulus in the range of 0.2 to 3.1 MPa would also be desirable.
  • acrylic copolymers e.g. silicone or collagen polymers
  • other types of materials e.g. silicone or collagen polymers which have similar physical and chemical characteristics as those described above could also be used and are all considered part of the present invention.
  • holes or pores may be provided in the implant to increase biocompatibility of the implant by allowing nutritive substances and gasses (e.g., water, glucose, and oxygen) to pass easily through the implant in order to maintain healthy metabolism in the cornea.
  • the polymer material may have thermoplastic properties such that the implant will have one desired shape at one temperature and then deform into another desired shape at a second temperature.
  • the corneal implant may comprise one or more separate, smaller components that can be assembled in situ placed inside the corneal pocket. Such in situ assembly advantageously minimizes the incision size needed to insert a corneal implant.
  • the corneal implant may be of any shape that allows it to be placed within a corneal pocket.
  • the corneal implant is substantially round.
  • the corneal implant is not round.
  • a corneal implant which is not round has the advantage that it is less likely to rotate within a corneal pocket. This property is useful in the implants which correct for astigmatism.
  • the corneal implant is a lens.
  • the lens can be a monofocal, multifocal, Fresnel, diffractive, prismatic, or other type of lens that can be used to treat refractive error (such as myopia, hyperopia, or astigmatism) presbyopia, or ocular disease e.g. macular degeneration.
  • the lens may also be made of a polymer that can have its refractive properties adjusted permanently or reversibly by electromagnetic energy as described in U.S. Patent Application 2003/0173691 to Jethmalani .
  • the corneal implant may comprise a prosthesis that is used to replace or augment a portion of the cornea. Such implants are useful in restoring optical clarity or structural integrity to the cornea in lieu of corneal transplantation.
  • the corneal prosthesis may be used to replace only a partial thickness portion of the cornea or a full thickness portion of the cornea.
  • the corneal implant may be coated with extracellular matrix proteins such as collagen, fibronectin, laminin, substance P, insulin-like growth factor-1, or peptide sequences such as fibronectin adhesion-promoting peptide (FAP).
  • these extracellular matrix proteins and peptides are tethered or otherwise bound to the epithelial side of the corneal implant by the methods described in U.S. Patent 6,689,165, to Jacob et al. Such surface treatments are intended to promote epithelialization on the surface of a corneal implant.
  • the surface of the corneal implant may have a texture that promotes epithelialization on the surface of the corneal implant. Textures, such as surface indentations, may be applied to the surface of the corneal implant to promote epithelialization, as described in U.S. Patent 6,454,800 to Dalton et al.
  • the corneal implant may be manufactured from a material that promotes epithelialization on the surface of the corneal implant.
  • materials include polymers selected from the group consisting of collagen and N-isopropylacrylamide, collagen and 1-ethyl-3.3'(dimethyl-aminopropyl)-carbodiimide as well as collagen and N-hydroxysuccinimide (EDC/NHS).
  • the polymer may additionally contain extracellular matrix proteins such as fibronectin, laminin, substance P, insulin-like growth factor-1, or peptide sequences such as fibronectin adhesion-promoting or peptide (FAP).
  • the device may contain holes or be porous in nature so as to promote growth of corneal tissue into and through the implant in order to promote retention and biocompatibility.
  • porous implants may be fabricated as described in U.S. Patent 6,976,997 to Noolandi et al. and U.S. Patent 5,300,116 to Chirila et al.
  • the lens or other corneal implant may be colored. Coloration can be useful for cosmetic purposes or for therapeutic purposes e.g. treatment of aniridia.
  • methods of applying biocompatible inks which are well known in colored contact lens manufacturing, may be used to color the corneal implant. Particular coloring methods are described in U.S. Patent Applications 2003/0054109 and 2003/0025873 , the disclosures of which are incorporated herein by reference.
  • the corneal implant may be colored with photosensitive inks that change color with exposure to electromagnetic waves. This allows the color of the corneal implant to be adjusted permanently or reversibly by exposure to electromagnetic waves in vivo.
  • the corneal implant may also contain an ultraviolet filter compound of the benzophenone type such as 3-(2 Benzyotriazolyl)-2-Hydroxy-5-Tert-Octyl-Benzyl Methacryl Amide.
  • an ultraviolet filter compound of the benzophenone type such as 3-(2 Benzyotriazolyl)-2-Hydroxy-5-Tert-Octyl-Benzyl Methacryl Amide.
  • the corneal implant may comprise a scaffold having a three-dimensional structure including discrete elements defining a peripheral shape with a mostly empty interior volume therein.
  • the predetermined shape is selected to provide a vision correction when placed in a corneal pocket.
  • the scaffold can be inserted into a corneal pocket for the purpose of reshaping or supporting the cornea. Reshaping of the cornea is useful for correction of various vision problems including refractive errors as well as for the treatment of ectactic corneal disorders such as keratoconus or pellucid marginal degeneration.
  • the corneal implant scaffold consists of a three dimensional structure where it is not possible for a single plane to pass through all of the elements of the structure.
  • the corneal implant scaffold is reversibly deformable so that it may be introduced to a corneal packet by the devices and methods of the present invention.
  • the corneal implant scaffold should have a rigidity that is greater than a mammalian cornea, so that insertion of the scaffold into a corneal pocket will result in either a change in shape of the cornea or be able to provide increased structural strength to the cornea.
  • the corneal implant scaffold is made of a biocompatible and reversibly deformable polymer or a biocompatible and reversibly deformable metal or alloy (e.g. gold, titanium, nitinol).
  • the width of the structural elements in the corneal implant scaffold is 0.1 mm to 1 mm, more, preferably 0.3 to 0.6 mm.
  • the thickness of the structural elements in the scaffold is 0.001 mm to 0.5 mm, more preferably 0.01 mm to 0.06 mm.
  • the cornea scaffold implant may also include a lens within the structure, which advantageously combines correction of refractive error by both changing of the shape of the cornea and the addition of another lens.
  • the corneal implant may be a device.
  • potential implant devices include miniature cameras and aqueous glucose monitors.
  • the improved corneal implants of the present invention are reversibly deformable into a reduced width shape that allows passage through a corneal incision that is substantially less than the width of the implant when undeformed or unconstrained.
  • the implant will be insertable through an incision that is less than or equal to one-half of the width of the implant, preferably being 3 mm or less.
  • a system according to the present invention comprises a hollow member and implant mover or other axial pusher used to deliver a corneal implant that has been constrained to fit inside an axial hollow passage of the hollow member.
  • the implant may be deformed or constrained in any shape or configuration having a "reduced width” that allows it to be fit inside of the hollow member e.g., rolled or folded.
  • reduced width it is meant that a maximum width of the implant, such as a diameter of a circular lens, is reduced by some threshold amount, typically by at least one-half (50%), often by at least 60%, and sometimes by 65% or more.
  • a system according to the present invention comprises a hollow member and implant mover used to deliver a corneal implant that has been restrained to fit inside of the hollow member. Once the corneal implant is inside the hollow member, the implant mover is used to move the implant into a corneal pocket or the anterior chamber.
  • the system may further comprise a deformation chamber where the implant is deformed into a shape and size that will fit inside the hollow member.
  • the deformation chamber may contain ridges, protrusions, indentations, or recesses which help to maintain and guide the orientation of the corneal implant within the deformation chamber during the deformation process.
  • the deformation chamber will be a size that is appropriate for the type of corneal implant which is being used. For example in the case of a corneal transplant, the minimum internal dimensions of an open deformation chamber should be between 6 and 10 mm, more preferably between 8 and 9 mm.
  • the minimum internal dimensions of an open deformation chamber dimensions should be between 1 mm and 10mm, more preferably between 2.0 mm and 7 mm.
  • the deformation area may be tapered or funnel shaped, i.e. narrower one end than on the other end. The tapered or funnel shape advantageously facilitates the corneal implant to be restrained to a smaller diameter configuration.
  • the interior of the hollow member may contain ridges, protrusions, indentations, or recesses which help to maintain and guide the orientation of the corneal implant as it travels inside of the hollow member. Such surface features will be arranged to prevent rotation of the corneal implant during insertion which might otherwise disorient the implant within the pocket.
  • the interior of the hollow member may contain ridges, protrusions, indentations, or recesses which guides a lamellar corneal stromal endothelial transplant to deform in a way which allows it to travel through a small incision without the need for folding or being grasped by forceps.
  • the system is designed to allow a corneal transplant to be placed through an incision equal or less than 3 mm. However, the system can also be used to place an implant through an incision that is greater than 3mm.
  • the system may be designed to be sterile and disposable for single use. This advantageously decreases the chance for contamination and infection. It also obviates the need for the surgeon to autoclave or to provide other methods of sterilization such as ethylene oxide. To insure that the system will be both sterile and single use only we can add one or more of the following features.
  • one or more components of the system may be made of a polymer which will melt or deform into an unusable shape upon autoclaving.
  • the system may have a one way locking mechanism, such that once the tip of the implant mover travels to a certain distance, the implant mover is locked in position inside of the hollow member, thus preventing reloading of another corneal implant.
  • the system may be assembled through the use of breakable tabs or snaps, which allows the secure assembly of the disposable component, but which are easily destroyed if there is an attempt to disassemble the system for reuse.
  • the system may be designed so that the corneal implant is pre-loaded inside of the hollow member prior to use by the surgeon. This advantageously minimizes the need for manipulation of the delicate corneal implant by the surgeon, which could result in damage to the corneal implant.
  • the implant mover or other axial pusher is used to engage and push the implant into the corneal pocket.
  • the system may further comprise a deformation chamber where the implant is deformed into a shape and size that will fit inside the hollow member.
  • the deformation chamber may contain ridges, protrusions, indentations, or recesses which help to maintain orientation of the corneal implant within the deformation chamber during the deformation process.
  • the hollow member is tapered, i.e., narrower at a distal end than at a proximal end. Such tapering allows additional deformation (size or width reduction) of the implant as it is advanced through the hollow member and passes out through a smaller distal opening.
  • the interior of the hollow member may contain ridges, protrusions, indentations, or recesses which help to maintain orientation of the corneal implant as it travels inside of the hollow member.
  • the system for implant placement is designed to allow an implant to be placed into a corneal pocket with an entry incision that is equal or less than one-half of the width of the implant, however, the system can also be used to place an implant through a corneal incision that is greater than one-half of the width of the implant.
  • Figure 1A shows a top view of a cataract surgery lens implant 2.
  • a round optic 5 of the implant 2 has haptics 10 which extend from the periphery of the optic.
  • the haptics 10 are used to help the optic center and fixate within the capsular bag.
  • Figure 1B shows a side view of a cataract surgery lens implant optic 5.
  • the thickness t 1 of the optic 5 is typically 1 mm or more and is substantially greater than the 0.5 to 0.6 mm thickness of the human cornea.
  • the thickness of the optic 5 makes it inappropriate for use as a corneal lens implant.
  • Figure 1C shows a top view of a corneal implant 15. Note there are no haptics on the corneal implant.
  • Figure 1D shows a side view of corneal implant 15.
  • the thickness t 2 is substantially less than cataract surgery lens implant 5.
  • the thickness t 2 of corneal implant 15 would in general be less than the thickness of the human cornea.
  • FIG 2A shows a corneal implant delivery system 18 in partial section.
  • Axial pusher 30 has a tip 35 that engages a corneal implant 15 that has been deformed in shape and constrained to fit inside the hollow axial passage 25 of the hollow member 20, as shown in Figure 2B .
  • the cross-section of hollow passage 25 may be circular, polygonal, or any other shape that is conducive to constraining the corneal implant 15.
  • the hollow axial passage 25 of the hollow member 20 may contain ridges, protrusions, indentations, or recesses (now shown) which help to maintain orientation of the corneal implant as it advances distally of the hollow member (not shown).
  • Axial pusher 30 engages one end of the constrained corneal implant 15 to advance the constrained implant through hollow passage 25.
  • Figure 2C shows the constrained corneal implant 15 emerging from a distal end of the hollow passage 25 still in its deformed and constrained configuration.
  • the corneal implant is able to pass through an entry incision that is less than one-half the width of the corneal implant.
  • the hollow member will have an external width from 0.5 mm to 5 mm, preferably from 1 mm to 3 mm and an internal width from 0.3 mm to 4.8 mm, preferably from 0.8 mm to 2.8 mm.
  • Figure 3A shows a side view of corneal implant 15 in its non-deformed, non-constrained shape.
  • Figure 3B and 3C shows an end on view of the corneal implant 15 as it is moved within the hollow member 20.
  • the corneal implant 15 has been deformed and constrained into a rolled configuration.
  • the rolled configuration will preferably have a diameter in the range from 0.3 mm to 4.8 mm, more preferably from 0.6 mm to 2.6 mm, to fit into the hollow passage 25 of the hollow member 20.
  • Figure 4A-4D shows a corneal implant delivery system with a deformation chamber 27 and a deforming member 28.
  • the corneal implant 15 is placed into the chamber 27 in an unconstrained and undeformed configuration and is then deformed into a folded or rolled corneal implant 17 within deformation chamber 27 by deforming member 28.
  • Deforming member 28 is moved within deformation chamber 27 to deform and fold corneal implant 15 into a folded or rolled corneal implant 17.
  • Figure 4C shows axial pusher 30 engaging deformed corneal implant 17 by implant mover tip 35.
  • Figure 4D shows deformed and folded corneal implant 17.
  • Axial pusher 30 engages corneal implant 17 to push the deformed constrained implant inside hollow passage 25.
  • Figure 4D shows that corneal implant 17 has been advanced by axial pusher 30 out of the hollow passage 25 while retaining a constrained shape.
  • the constrained configuration of corneal implant 17 allows passage into the corneal pocket (not shown) through a small incision.
  • the presence of the optional deformation chamber 27 and deforming member 28, advantageously allows the corneal implant 15 to be easily deformed into a configuration that will allow it to be placed through a small corneal incision into a corneal pocket.
  • Figures 5A-5D show side views of the corneal implant 15 being deformed into an exemplary deformed and folded or pleated corneal implant 17.
  • FIGS 6A-6C show a top view of an alternative corneal implant delivery system 100.
  • a corneal implant 115 is placed into a deformation area 122.
  • a deformation chamber 124 ( Figure 6B ) is formed which deforms the corneal implant 115.
  • the corneal implant 115 is folded in half.
  • a tip 132 of an axial pusher 130 engages corneal implant 115.
  • the hollow member 120 is tapered so that hollow passage 126 is narrower at a distal end 121 that inserts into the corneal pocket. This allows the corneal implant 115 to be deformed into an even smaller cross-section as the implant is advanced distally and through the distal end 121.
  • the implant mover tip 132 may also be deformable to fit within the narrowing hollow passage 126.
  • Figure 7A shows a side cross-sectional view of corneal implant 115 being inserted into corneal pocket 140.
  • Figure 7B shows the final shape of corneal implant 115 after it has been inserted into corneal pocket 140 and unfurled or otherwise expanded back to its unconstrained size within cornea 145.
  • FIG 8A illustrates a cross-sectional view of a corneal implant prosthesis 50
  • Corneal implant 50 is meant to replace a portion of the anterior layers of the cornea.
  • the central optic would protrude anteriorly from the rim by 1 to 600 microns. More preferably, the central optic would protrude anteriorly from the rim by 50 to 400 microns.
  • the central optic 52 will replace diseased anterior corneal tissue that has been removed.
  • the rim 54 is designed to partly or fully surround the center of optic and to fit within the peripheral recesses of a corneal pocket in order to anchor the corneal implant prosthesis to the cornea.
  • the rim may be a continuous skirt as illustrated or may be crenellated or otherwise distributed in sections about the periphery of the center optic.
  • Figure 8B shows a top view of corneal implant prosthesis 50 which shows the central optic 52 and the rim 54.
  • the rim 54 may optionally contain holes or be porous in nature so as to promote growth of corneal tissue into and through the implant, in order to promote retention and biocompatibility.
  • FIG. 8C shows a cross-sectional view of corneal implant prosthesis 60 which is meant to replace a full-thickness area of the cornea.
  • central optic 62 which protrudes anteriorly from a rim 64.
  • the anterior portion of central optic 62 will replace diseased anterior corneal tissue that has been removed.
  • the central optic would protrude anteriorly from the rim by 1 to 600 microns. More preferably, the central optic would protrude anteriorly from the rim by 50 to 400 microns.
  • corneal implant prosthesis 60 has a posterior portion of central optic 66 which protrudes posteriorly from rim 64. In preferred aspects, the central optic would protrude posteriorlyfrom the rim by 1 to 900 microns.
  • the central optic would protrude posteriorly from the rim by 50 to 800 microns.
  • the posterior portion of central optic 63 will replace diseased posterior corneal tissue that has been removed.
  • the rim 64 will anchor corneal implant prosthesis 60 within the peripheral recesses of the corneal pocket and provide a water-tight seal.
  • the rim 64 may optionally contain holes or be porous in nature so as to promote growth of corneal tissue into and through the implant, in order to promote retention and biocompatibility.
  • the rim may be formed from any of the lens materials described above.
  • Figures 9A-9F show a method of treating an anterior corneal disease process using the methods and apparatus of the present invention.
  • a cross-sectional view of the cornea is seen above and a top view is seen below.
  • pocket 40 has been created posterior to anterior diseased cornea 43.
  • Figure 9B shows that anterior diseased cornea 43 has been excised with a circular trephine (not shown) to create an open top having a peripheral pocket. The edge of the excision is shown as 45.
  • Figure 9B also shows corneal implant 50 resting in the deformation area 122.
  • the hollow member 120 has been inserted into pocket 40 through external opening 42 and corneal implant 50 has been folded in half within deformation chamber 124.
  • FIG 9D shows that corneal implant 50 has been further deformed into a more compact shape by its movement through narrowing hollow passage 126 and is being extruded into pocket 40.
  • Figure 9E shows that corneal implant 50 has been restored to its original shape within corneal pocket 40.
  • Central optic 52 fills the space left by excised diseased anterior cornea 43 and restores optical clarity to the cornea.
  • Hollow member 120 and implant mover 30 have been withdrawn from corneal pocket 40.
  • Figure 9F shows the final appearance of corneal implant 50 fixated within corneal pocket 40.
  • FIGs 10 A-10F show a method of treating a full-thickness corneal disease (e.g. pseudophakic bullous keratopathy) through the use of the present invention.
  • a cross-sectional view of the cornea is seen above and a top view is seen below.
  • pocket 40 has been created within the layers of the diseased cornea 41.
  • the pocket divides the cornea into diseased anterior cornea 43 and diseased posterior cornea 44.
  • Figure 10B shows that anterior diseased cornea 43 has been excised with a circular trephine (not shown).
  • the edge of the excision is shown in dashed lines as 45.
  • the opening in the anterior cornea within the edge of the excision 45 is shown at reference number 46.
  • Figure 10B also shows corneal implant 60 resting in the deformation charter or area 122.
  • the hollow member 120 has been inserted into pocket 40 through external opening 42 and corneal implant 60 has been folded in half within deformation chamber 122.
  • Figure 10D shows that corneal implant 60 has been further deformed into a more compact shape by its movement through narrowing hollow passage 126 and is being extruded into pocket 40.
  • Figure 10E shows that corneal implant 60 has been restored to its original shape within corneal pocket 40.
  • Anterior optic 62 fills the space left by the excised diseased anterior cornea 43.
  • the posterior diseased cornea 44 can be excised with low profile curved corneal scissors or some other cutting tool (e.g.
  • FIG. 10F shows the final appearance of corneal implant prosthesis 60.
  • the rim 64 anchors corneal implant prosthesis 60 within the peripheral recesses of the corneal pocket and provides a water-tight seal.
  • posterior optic 63 protrudes through the space left by excised diseased cornea 44.
  • posterior optic 63 is optional and is not necessarily required for the corneal implant to properly function. It is to be understood that the relative dimensions, shapes, and angles of the anterior central optic 62, posterior central optic 63, and rim 64, may each be modified to promote improved retention as well as optical qualities all in keeping within the scope of the present invention.
  • the corneal implant 60 may be introduced into the pocket 40 using the injector system as described previously in Figures 9 and 10 through an opening 46.
  • the hollow member 120 may be inserted through the opening 46, and the corneal implant 60 then injected into the pocket 40.
  • the corneal implant 60 may be placed into the pocket 40 by constraining the corneal implant 60 into a small diameter configuration (e.g. with forceps) and inserting it through the opening 46 into the pocket 40 without the use of the hollow member 120 (not shown).
  • Figure 11A-11F show an embodiment of a corneal implant that can be assembled within the corneal pocket. By assembling individual smaller pieces of the corneal implant within the corneal pocket, a relatively large corneal implant can be constructed while using a relatively small external incision.
  • the top portion of Figures 11A and 11B show a cross-sectional view of a cornea with an intra-stromal pocket.
  • the bottom portion of Figure 11A shows a top down view of a cornea with an intra-stromal pocket.
  • the rim may be made of a relatively rigid material e.g. polymethylmethacrylate (PMMA) and still be inserted through the external opening 42 that is less than half of the diameter of the assembled corneal implant.
  • PMMA polymethylmethacrylate
  • the vertical dashed lines in the top of the figure and the circular dashed lines in the bottom figure represent an opening 76 left by a circular disk of anterior stromal tissue that has been excised (e.g. with a trephine).
  • Figures 11C and 11D show that the optic 72 may fit into opening 76.
  • Figures 11E and 11F show that the optic 72 has been attached to the two halves of the rim 70 and 74 to complete assembly of the corneal implant.
  • the individual pieces of the corneal implant may be attached to each other by interlocking fittings (not shown), by glue, or any other appropriate mechanical or chemical method of fixation.
  • the corneal implant is shown as a three piece prosthesis that replaces part of the cornea.
  • the invention includes any corneal implant that can be assembled as two or more pieces within a corneal pocket.
  • Figures 12A-12B are end views of the back of a deformation chamber 86 on a hollow member 80 which show how the presence of a protrusion 82 within the deformation chamber can help to maintain the orientation of a corneal implant 90 as it is pushed in an axial direction.
  • Deformation chamber 86 includes three hinged sections 80a, 80b, and 80c which make up a hollow member which opens in order to receive corneal implant 90.
  • At the lateral aspects of deformation area 80 are two protrusions 82, which help to hold the rim 94 of corneal implant 90 in place.
  • Figure 12B shows how sections 80a, 80b, and 80c can be closed by putting together the wings 84 (which together form an axial pusher or implant mover) to create hollow member 80 and deformation chamber 86.
  • Corneal implant 90 is now securely fixated within the hollow deformation chamber 86 by the protrusions 82 and can be manipulated.
  • the corneal implant 90 can then be moved axially along hollow member 80 by an axial pusher or other implant mover(not shown) without inadvertent rotation of the corneal implant.
  • the corneal implant could be colored in any of the embodiments of the invention to enhance the aesthetic appearance of the eye or to decrease the amount of light exposure to the eye (e.g. for treatment of aniridia).
  • a corneal implant insertion device 200 includes a deformation chamber 202 defined by two-circular hinged sections 204.
  • the hinged sections 204 are attached to wings 206 which permit the hinged sections to be closed in order to capture the corneal implant C, after the implant has been introduced into the deformation chamber, as shown in Figure 13B .
  • Protrusions 210 having interior arcuate surfaces 212 are attached to the hinged sections 204 so that the surfaces 212 form radially inwardly directed ramps, as illustrated in Figure 14A .
  • closure of the chamber using the wings 206 will curl the corneal implant C into a C-shaped profile, as shown in Figure 14A .
  • This can be an advantage over the corneal insertion tool embodiment of Figures 12A and 12B where the edges of the implant are held in a generally open configuration by the outwardly facing surfaces of protrusions 82.
  • the corneal implant C comprises a lamellar corneal stromal endothelial transplant graft of approximately 9 mm in diameter and 100 ⁇ m in thickness.
  • the deformation chamber 220 has a diameter or width D of approximately 9 mm in order to receive the corneal implant C such that its edges are disposed beneath the arcuate surfaces 212 of the protrusions 210, as illustrated in Figure 13B .
  • a pusher shaft 230 having a forward member 232 may be advanced into the deformation chamber 202 of the corneal implant insertion device 200.
  • the forward element 232 will have a profile which is similar to the shape of the hollow passage so that it can pass over the protrusions 210 and will typically be compressible so that it can pass into a tapered region 240 of the insertion device, as shown in Figure 15D .
  • the forward member 232 will first be introduced into the constant-diameter portion of the deformation chamber 202, as shown in Figure 15B , and used to advance the corneal implant C forwardly.
  • the shaft 30 and forward member 232 will continue to be advanced so that the corneal implant C is pushed from the distal tip of the tapered region 240, as shown in Figure 15C .
  • the corneal implant C As the corneal implant C is advanced, its edges will be curved or everted inwardly, as illustrated in Figures 14A through 14C .
  • the corneal implant C is shown as it is in Figure 15A .
  • the corneal implant C As it advances forwardly, as shown in Figure 15B , the corneal implant C is reduced in diameter with the edges being pushed radially inwardly, as shown in Figure 14B .
  • the corneal implant C is released from the proximal tip of the tapered region 240, it has a significantly reduced diameter, as shown in Figure 14C . It is particularly desirable that the corneal implant C be reduced in size to as great an extent as possible but that the leading tips of the implant not touch the interior surface, just as shown in Figure 14C . This reduces the damage or trauma to the delicate corneal endothelial cells during the implantation protocol.
  • a graft C such as a DSEK or DMEK graft
  • Implant mover 300 has a flexible platform 310 which provides a loading area and which consists of a thin flexible material, such as a plastic.
  • Figure 16A shows the DSEK or DMEK graft C on the platform 310 from a top view.
  • Figure 16B shows the DSEK or DMEK graft C on the platform 310 in side profile.
  • Figure 16E shows the DSEK or DMEK graft on the platform 310 from a front view at the start of the loading process.
  • Figure 16E is shown at the same time point of the loading process as Figure 16A and 16B.
  • Figure 16C is a top view which shows that when platform 310 is pulled into a hollow member 320 by implant mover member 300 that the flexible platform 310 will become constrained in size and shape. Because the DSEK or DMEK graft C is flexible it will also become constrained in size and shape inside the flexible platform 310.
  • Figure 16D shows a side view at the same time point as 16C.
  • Figure 16F shows how DSEK or DMEK graft C is restrained inside flexible platform 310 into a small diameter configuration.
  • FIGs 16A-D and 16F an internal arcuate protrusion 330 will force the flexible platform 310 and DSEK graft C to curl in a way that engages only the stromal surface, thereby protecting the delicate corneal endothelium located on the inside of the DSEK or DMEK Graft C.
  • hollow member 320 is advanced into the corneal or scleral incision.
  • Implant mover 300 is then advanced, allowing flexible platform 310 and DSEK Graft C so that DSEK Graft C can unfurl and be released into the anterior chamber.
  • Figures 16A-D show an optional bevel to the end of hollow member 320 which advantageously allows for easier insertion into the ocular incision.
  • the optional bevel has an angle between 1° and 89°, preferably between 25° and 65°.
  • Figure 17A shows a top view of a corneal scaffold implant 400 which is designed for correcting myopia.
  • the scaffold implant 400 is formed from discrete elements 402 which provide a peripheral shape which is a truncate dome. An interior volume of the dome is empty and free from structure.
  • Figure 17B is an oblique view which shows the shape of the cornea C prior to insertion of the corneal scaffold implant 400 for myopia into a corneal pocket through incision I.
  • Figure 17C shows how the insertion of corneal scaffold implant for myopia 400 flattens the cornea in the direction of the arrow 404 and thereby reduces myopia.
  • FIG 18A shows a top view of a corneal scaffold implant 410 which is designed for the purpose of correcting hyperopia.
  • the implant 410 comprises elements 412 which form a higher truncated dome than implant 400.
  • Figure 18B shows how the insertion of this corneal scaffold implant for hyperopia 410 steepens the cornea in the direction of the arrow and thereby reduces hyperopia.
  • FIG 19A shows a top view of a corneal scaffold implant 420 which is designed for the purpose of correcting hyperopic astigmatism.
  • the implant 420 comprises two lateral wings 422 joined by a central ring 424.
  • Figure 19B shows how the insertion of this corneal scaffold implant for hyperopic astigmatism 420 steepens the central cornea in the direction of the arrow and thereby reduces hyperopia and also flattens the steep axis of the cornea thereby reducing astigmatism.
  • Figure 20A shows a top view of a corneal scaffold implant 430 which also contains a lens L shown in hatched lines.
  • Figure 20B shows how the insertion of this corneal scaffold implant with a lens 430 corrects refractive error by both changing the shape of the cornea (flattening in this case) and by introducing an additional lens to the optical system.
  • the scaffold may be formed from the same polymers as described previously by common techniques, such as molding. Many other shapes and structures for the corneal scaffold implant can be devised for the treatment of myopia, hyperopia, astigmatism, higher order aberrations and ectactic corneal diseases. Our invention includes all of the possible three dimensional shapes and structures where it is not possible for a single plane to pass through all of the elements of the structure.
EP18181352.8A 2007-04-27 2008-04-25 Systeme zur platzierung von hornhaut-implantaten Active EP3434226B1 (de)

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US11/741,496 US8029515B2 (en) 2005-01-31 2007-04-27 Corneal implants and methods and systems for placement
EP08780570.1A EP2142150B1 (de) 2007-04-27 2008-04-25 Systeme zur platzierung von hornhautimplantaten
PCT/US2008/061656 WO2008134573A1 (en) 2007-04-27 2008-04-25 Corneal implants and methods and systems for placement

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EP15167678.0A Active EP2954873B1 (de) 2007-04-27 2008-04-25 Hornhautimplantate
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EP15167678.0A Active EP2954873B1 (de) 2007-04-27 2008-04-25 Hornhautimplantate

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EP (4) EP2404573B1 (de)
JP (4) JP5323813B2 (de)
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JP2010524654A (ja) 2010-07-22
ES2854999T3 (es) 2021-09-23
US8029515B2 (en) 2011-10-04
EP2954873A1 (de) 2015-12-16
JP2014128739A (ja) 2014-07-10
CN102397116A (zh) 2012-04-04
CN101715334A (zh) 2010-05-26
JP2013126583A (ja) 2013-06-27
JP5323813B2 (ja) 2013-10-23
CN102397116B (zh) 2016-06-22
EP2142150A4 (de) 2012-01-04
US20070244559A1 (en) 2007-10-18
JP2015110089A (ja) 2015-06-18
ES2690320T3 (es) 2018-11-20
EP2404573A1 (de) 2012-01-11
JP5944339B2 (ja) 2016-07-05
EP2142150A1 (de) 2010-01-13
HK1213169A1 (zh) 2016-06-30
EP2142150B1 (de) 2018-08-15
EP3434226B1 (de) 2020-11-18
EP2404573B1 (de) 2013-03-27
JP5806361B2 (ja) 2015-11-10
CN104814809A (zh) 2015-08-05
EP2954873B1 (de) 2019-11-06
ES2404174T3 (es) 2013-05-24
WO2008134573A1 (en) 2008-11-06
ES2768577T3 (es) 2020-06-23

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